FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
95209–95232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1996
SURGIFLATOR-20 PIM
K955791 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 361d
Cleared Dec 17, 1996
1ST RESPONSE DISPOSABLE MANOMETER
K961318 · CAP
Intertech Resources, Inc.
Anesthesiology · 256d
Cleared Dec 17, 1996
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT...
K962185 · LPL
CooperVision, Inc.
Ophthalmic · 194d
Cleared Dec 17, 1996
BARD COAGULATING RESECTOR MODEL (3552XX
K962538 · FAS
C.R. Bard, Inc.
Gastroenterology & Urology · 172d
Cleared Dec 17, 1996
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
K962572 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 169d
Cleared Dec 17, 1996
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894 · HRS
Synthes (Usa)
Orthopedic · 145d
Cleared Dec 17, 1996
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · HCG
Target Therapeutics
Neurology · 117d
Cleared Dec 17, 1996
HIGH PRESSURE INJECTION LINES
K963749 · DTL
Maxxim Medical
Cardiovascular · 90d
Cleared Dec 17, 1996
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
K963993 · FCM
Rusch, Inc.
Gastroenterology & Urology · 74d
Cleared Dec 17, 1996
EYE FIXATION SPECULUM
K964289 · HNC
Eyefix, Inc.
Ophthalmic · 50d
Cleared Dec 17, 1996
PLASTIC SUNGLASSES
K964316 · HQY
Medical Reports Exchange, Inc.
Ophthalmic · 49d
Cleared Dec 17, 1996
PERSONAL TELEMEDICINE MODULE
K964554 · DRG
American Telecare, Inc.
Cardiovascular · 34d
Cleared Dec 16, 1996
ISLAND BIOSURGICAL BOLSTER
K960101 · OTN
Island Biosurgical, Inc.
Gastroenterology & Urology · 340d
Cleared Dec 16, 1996
ADVANTAGE MAPF HIP FEMORAL COMPONENT
K960643 · KWY
Biomet, Inc.
Orthopedic · 306d
Cleared Dec 16, 1996
NOVUS STANDARD AND PEDIATRIC VALVES
K961859 · JXG
Integra Neurocare, LLC
Neurology · 216d
Cleared Dec 16, 1996
THERATEST EL-RFSCR
K962050 · DHR
Theratest Laboratories, Inc.
Immunology · 202d
Cleared Dec 16, 1996
CELSITE PORT WITH PRECONNECTED CATHETER
K962230 · LJT
B.Braun Medical, Inc.
General Hospital · 189d
Cleared Dec 16, 1996
EEG ELECTRODES
K962283 · GXY
Teca, Inc.
Neurology · 186d
Cleared Dec 16, 1996
STREPTOLEX-STAT
K962296 · GTZ
Unipath , Ltd.
Microbiology · 187d
Cleared Dec 16, 1996
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
K962641 · DTZ
Medtronic Vascular
Cardiovascular · 164d
Cleared Dec 16, 1996
MULTIDEX HYDROPHILIC WOUND DRESSING GEL
K962917 · MGQ
Lange Medical Products, Inc.
General & Plastic Surgery · 143d
Cleared Dec 16, 1996
CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER
K963094 · GEX
Cynosure, Inc.
General & Plastic Surgery · 130d
Cleared Dec 16, 1996
ELECSYS FT3
K963127 · CDP
Boehringer Mannheim Corp.
Chemistry · 126d
Cleared Dec 16, 1996
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · LGD
Incstar Corp.
Microbiology · 117d